Kitov Pharmaceuticals Hldgs L Sponsored ADR (KTOV)

[midastouch017]

Kitov Announces Consensi™ as Brand Name for KIT-302

TEL AVIV, Israel, December 14, 2017 /PRNewswire/ --

Kitov Pharmaceuticals KTOV, +2.93% (tase:KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food & Drug Administration (FDA) has granted permission to Kitov to use the brand name Consensi™ for marketing KIT-302, subject to receipt of marketing approval from the FDA.

"The receipt of the FDA's permission to use Consensi as the brand name for our lead drug is another important step in executing on our corporate strategy and will facilitate the commercialization of KIT-302, once approved by the FDA, " stated J. Paul Waymack, M.D., Sc.D., Kitov's Chairman of the Board and Chief Medical Officer.

Consensi™ is a combination drug that is intended to simultaneously treat pain caused by osteoarthritis, as well as hypertension, which is a common side effect of stand-alone drugs that treat osteoarthritis pain. Consensi™ is comprised of two FDA approved drugs, celecoxib (Celebrex [®] ), a COX-2 inhibitor, for the treatment of pain caused by osteoarthritis, and amlodipine besylate (Norvasc [®] ), a calcium channel blocker for lowering blood pressure.

In September 2017, the FDA filed Kitov's New Drug Application (NDA) for Consensi™ and, under the Prescription Drug User Fee Act (PDUFA), set a target date of May 31, 2018 to complete its review.